We use cookies to understand how you use our site and to improve your experience.
This includes personalizing content and advertising.
By pressing "Accept All" or closing out of this banner, you consent to the use of all cookies and similar technologies and the sharing of information they collect with third parties.
You can reject marketing cookies by pressing "Deny Optional," but we still use essential, performance, and functional cookies.
In addition, whether you "Accept All," Deny Optional," click the X or otherwise continue to use the site, you accept our Privacy Policy and Terms of Service, revised from time to time.
You are being directed to ZacksTrade, a division of LBMZ Securities and licensed broker-dealer. ZacksTrade and Zacks.com are separate companies. The web link between the two companies is not a solicitation or offer to invest in a particular security or type of security. ZacksTrade does not endorse or adopt any particular investment strategy, any analyst opinion/rating/report or any approach to evaluating individual securities.
If you wish to go to ZacksTrade, click OK. If you do not, click Cancel.
J&J (JNJ) Submits NDA for Single Tablet Combo to Treat PAH
Read MoreHide Full Article
J&J (JNJ - Free Report) announced the submission of a new drug application (NDA) to the FDA for the approval of its once-daily single tablet, constituting macitentan 10mg and tadalafil 40mg (M/T STCT), for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization’s functional class II-III.
The NDA is based on positive data from J&J’s phase III A DUE study, evaluating the efficacy and safety of investigational M/T STCT versus macitentan and tadalafil monotherapies in patients with PAH. The study met its primary endpoint, demonstrating statistically significant improvement in pulmonary hemodynamics (blood flow through pulmonary blood vessels) upon treatment with M/T STCT compared with macitentan and tadalafil monotherapies in the above-mentioned PAH patient population.
In the year so far, shares of J&J have decreased 12.6% compared with the industry’s brisk 0.8% decline.
Image Source: Zacks Investment Research
In the phase III A DUE study, the safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafil. The open-label arm of the A DUE study is currently ongoing.
Management claims that treatment with M/T STCT has the potential to improve patient convenience by reducing their pill burden. PAH patients are often prescribed numerous medicines to manage their condition. Subject to approval, M/T STCT could become a single tablet combination of two guideline-recommended therapies, decreasing the pill burden of patients along with improving patient treatment experience and clinical outcomes.
JNJ currently markets macitentan 10mg under the brand name Opsumit as monotherapy or in combination, which is indicated for the long-term treatment of PAH. Opsumit generated revenues worth $440 million worldwide in the first quarter of 2023.
PAH is a rare and progressive cardiovascular disorder that causes the arteries, lungs and right side of the heart to get narrowed, blocked or destroyed, eventually leading to right heart failure.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.61 to $2.31. In the year so far, shares of Allogene Therapeutics have fallen by 17.5%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the year so far, shares of Akero Therapeutics have fallen by 19.9%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the year so far, shares of ADMA Biologics have gained by 4.1%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.
See More Zacks Research for These Tickers
Normally $25 each - click below to receive one report FREE:
Image: Bigstock
J&J (JNJ) Submits NDA for Single Tablet Combo to Treat PAH
J&J (JNJ - Free Report) announced the submission of a new drug application (NDA) to the FDA for the approval of its once-daily single tablet, constituting macitentan 10mg and tadalafil 40mg (M/T STCT), for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients with World Health Organization’s functional class II-III.
The NDA is based on positive data from J&J’s phase III A DUE study, evaluating the efficacy and safety of investigational M/T STCT versus macitentan and tadalafil monotherapies in patients with PAH. The study met its primary endpoint, demonstrating statistically significant improvement in pulmonary hemodynamics (blood flow through pulmonary blood vessels) upon treatment with M/T STCT compared with macitentan and tadalafil monotherapies in the above-mentioned PAH patient population.
In the year so far, shares of J&J have decreased 12.6% compared with the industry’s brisk 0.8% decline.
Image Source: Zacks Investment Research
In the phase III A DUE study, the safety profile of M/T STCT was consistent with the safety profile of the individual components, macitentan and tadalafil. The open-label arm of the A DUE study is currently ongoing.
Management claims that treatment with M/T STCT has the potential to improve patient convenience by reducing their pill burden. PAH patients are often prescribed numerous medicines to manage their condition. Subject to approval, M/T STCT could become a single tablet combination of two guideline-recommended therapies, decreasing the pill burden of patients along with improving patient treatment experience and clinical outcomes.
JNJ currently markets macitentan 10mg under the brand name Opsumit as monotherapy or in combination, which is indicated for the long-term treatment of PAH. Opsumit generated revenues worth $440 million worldwide in the first quarter of 2023.
PAH is a rare and progressive cardiovascular disorder that causes the arteries, lungs and right side of the heart to get narrowed, blocked or destroyed, eventually leading to right heart failure.
Johnson & Johnson Price and Consensus
AJohnson & Johnson price-consensus-chart | Johnson & Johnson Quote
Zacks Rank and Stocks to Consider
J&J currently has a Zacks Rank #3 (Hold).
Some better-ranked stocks in the biotech sector are Allogene Therapeutics (ALLO - Free Report) , Akero Therapeutics (AKRO - Free Report) and ADMA Biologics, Inc. (ADMA - Free Report) , each carrying a Zacks Rank #2 (Buy) at present. You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
In the past 90 days, the Zacks Consensus Estimate for Allogene Therapeutics’ 2023 loss per share has narrowed from $2.61 to $2.31. In the year so far, shares of Allogene Therapeutics have fallen by 17.5%.
ALLO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 5.08%.
In the past 90 days, the Zacks Consensus Estimate for Akero Therapeutics’ 2023 loss per share has narrowed from $3.46 to $2.78. In the year so far, shares of Akero Therapeutics have fallen by 19.9%.
AKRO beat estimates in three of the trailing four quarters, missing the mark on one occasion, delivering an average earnings surprise of 7.96%.
In the past 90 days, the Zacks Consensus Estimate for ADMA Biologics’ 2023 loss per share has narrowed from 19 cents to 9 cents. In the year so far, shares of ADMA Biologics have gained by 4.1%.
ADMA beat estimates in each of the trailing four quarters, delivering an average earnings surprise of 19.13%.